Healthy VolunteerPhase 2NCT04087707
Safety, Pharmacokinetic, and Pharmacodynamic Study of TS-142 in Healthy Subjects
A Phase 2 study testing Step 1: TS-142 and Step 2: TS-142 in people with Healthy Volunteer, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to investigate the safety, pharmacokinetics, and pharmacodynamics of repeated dosing of TS-142 when administered once daily to healthy Japanese non-elderly and elderly participants Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Step 1: TS-142 and Step 2: TS-142
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteJapan
- Study dates
- 17 Sep 2019to 30 Nov 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) ≥18.5 and <25.0 kg/m^2 and body weight is more than 40.0 kg at screening inspection
- Other protocol defined inclusion criteria could apply
Who cannot join
- History of clinically relevant disease of any organ system that may interfere with the objectives of the study or provide a risk to the health of the participant
- History of drug and food allergy
- Other protocol defined exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Pharmacological Study of TS-142 in Non-Elderly and Elderly Healthy Participants (A Repeated-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TS-142 in Elderly and Non-Elderly Participants)
The purpose of this study is to investigate the safety, pharmacokinetics, and pharmacodynamics of repeated dosing of TS-142 when administered once daily to healthy Japanese non-elderly and elderly participants
- Conditions
- Healthy Volunteer
- Being tested
- Step 1: TS-142, Step 2: TS-142, Step 2: Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step 1: TS-142Drug
Non-elderly participants will receive 20 mg of TS-142 once daily for 7 consective days
Step 2: TS-142Drug
Elderly participants will receive 20 mg of TS-142 once daily for 7 consective days
Step 2: PlaceboDrug
Elderly participants will receive placebo once daily for 7 consective days
| Study group | Role | What they receive |
|---|---|---|
| Step 1;TS-142 | Experimental | Not described Receives: Drug: Step 1: TS-142 |
| Step 2;TS-142 | Experimental | Not described Receives: Drug: Step 2: TS-142; Drug: Step 2: Placebo |
| Step 2;Placebo | Placebo comparator | Not described Receives: Drug: Step 2: TS-142; Drug: Step 2: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
Number of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) reported as mild, moderate, severe
Measured: Day 1 up to Day 14
Area under the concentration-time curve AUC (tau)
Concentration of TS-142 and its metabolites in plasma
Measured: Day 1 up to Day 9
Step2; Subjective Alertness via Karolinska Sleepiness Scale (KSS)
Step2; as a measure of subjective alertness which is scored by 10 cm-VAS scale ranging from 1, extremely alert, to 9, extremely sleepy at the next morning after administration.
Measured: Day 1 up to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start17 Sep 2019
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taisho Director, Study director, Taisho Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087707
- Sponsor's protocol ID
- TS142-202
- Status last verified
- Dec 2019
- First submitted
- 9 Sep 2019
- Last updated
- 28 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kambe D, Hasegawa S, Imadera Y, Mano Y, Matsushita I, Konno Y, Ogo H, Uchimura N, Uchiyama M. Pharmacokinetics, pharmacodynamics and safety profile of the dual orexin receptor antagonist vornorexant/TS-142 in healthy Japanese participants following single/multiple dosing: Randomized, double-blind, placebo-controlled phase-1 studies. Basic Clin Pharmacol Toxicol. 2023 Nov;133(5):576-591. doi: 10.1111/bcpt.13930. Epub 2023 Sep 10.
PubMed 37563858
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Pharmacological Study of TS-142 in Non-Elderly and Elderly Healthy Participants (A Repeated-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of TS-142 in Elderly and Non-Elderly Participants)
- ClinicalTrials.gov ID
- NCT04087707
- Acronym / sponsor ID
- TS142-202
- Conditions
- Healthy Volunteer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Taisho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the safety, pharmacokinetics, and pharmacodynamics of repeated dosing of TS-142 when administered once daily to healthy Japanese non-elderly and elderly participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Step 1;TS-142 | Experimental | Drug: Step 1: TS-142 |
| Step 2;TS-142 | Experimental | Drug: Step 2: TS-142, Drug: Step 2: Placebo |
| Step 2;Placebo | Placebo comparator | Drug: Step 2: TS-142, Drug: Step 2: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) ≥18.5 and <25.0 kg/m^2 and body weight is more than 40.0 kg at screening inspection
- Other protocol defined inclusion criteria could apply
Key exclusion criteria (3 listed)
- History of clinically relevant disease of any organ system that may interfere with the objectives of the study or provide a risk to the health of the participant
- History of drug and food allergy
- Other protocol defined exclusion criteria could apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Step 1: TS-142Non-elderly participants will receive 20 mg of TS-142 once daily for 7 consective days | Drug | Step 1;TS-142 |
| Step 2: TS-142Elderly participants will receive 20 mg of TS-142 once daily for 7 consective days | Drug | Step 2;Placebo, Step 2;TS-142 |
| Step 2: PlaceboElderly participants will receive placebo once daily for 7 consective days | Drug | Step 2;Placebo, Step 2;TS-142 |
Primary outcome
Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
Time frame: Day 1 up to Day 14
Number of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) reported as mild, moderate, severe
Area under the concentration-time curve AUC (tau)
Time frame: Day 1 up to Day 9
Concentration of TS-142 and its metabolites in plasma
Step2; Subjective Alertness via Karolinska Sleepiness Scale (KSS)
Time frame: Day 1 up to Day 8
Step2; as a measure of subjective alertness which is scored by 10 cm-VAS scale ranging from 1, extremely alert, to 9, extremely sleepy at the next morning after administration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Results publication: PubMed 37563858Kambe D, Hasegawa S, Imadera Y, Mano Y, Matsushita I, Konno Y, Ogo H, Uchimura N, Uchiyama M. Pharmacokinetics, pharmacodynamics and safety profile of the dual orexin receptor antagonist vornorexant/TS-142 in healthy Japanese participants following single/multiple dosing: Randomized, double-blind, placebo-controlled phase-1 studies. Basic Clin Pharmacol Toxicol. 2023 Nov;133(5):576-591. doi: 10.1111/bcpt.13930. Epub 2023 Sep 10.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taisho Director study director
Taisho Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Step 1: TS-142 and Step 2: TS-142 in people with Healthy Volunteer, run by Taisho Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) (time frame: Day 1 up to Day 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04087707, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.